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Trial record 7 of 2159 for:    doxorubicin

A Study With Intraperitoneal Cisplatin and Doxorubicin in Recurrent Ovarian Cancer and Peritoneal Carcinomatosis

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ClinicalTrials.gov Identifier: NCT02475772
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Clemens Tempfer, Ruhr University of Bochum

Brief Summary:
Fifteen women with recurrent ovarian cancer will be treated by an intraperitoneal chemotherapy with cisplatin and doxorubicin in three escalating dosage schedules. The aim of the study is to evaluate the safety and tolerability of doxorubicin and cisplatin every 4 weeks for three courses using a three-group, dose-escalation protocol with fixed dose-density. The time Frame for the assessment of the Primary outcome is therefore 12 weeks. Predefined toxicity criteria will be applied using CTCAE version 4.0 criteria. The study hypothesis is that local and systemic toxicity will increase with increasing dosage of cisplatin and doxorubicin during three repeated PIPAC courses with no CTCAE grade 4 and 5 events in any treatment group.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Cisplatin and doxorubicin Procedure: Cisplatin and doxorubicin Phase 1

Detailed Description:

This is a prospective phase I, single-arm (nonrandomized), open-label, three step dose-escalation study with cisplatin and doxorubicin applied as PIPAC in 15 patients with recurrent ovarian cancer and peritoneal cancer.

The first 5 patients will receive doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 2.25 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 11.25 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 3 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 15 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. This schedule represents a three-step, 50% dose-escalation. Dose density will not be changed.

The aim of this study is to evaluate the safety and tolerability of doxorubicin and cisplatin every 4-6 weeks for three courses using a three-group, dose-escalation protocol with fixed dose-density. The time Frame for the assessment of the Primary outcome is therefore 12 weeks. Predefined toxicity criteria will be applied using CTCAE version 4.0 criteria, documented after the first, second, and third course of treatment. Clinical examinations will include abdominal computed tomography (CT) scans after the first, second, and third course of treatment, cardiac echocardiography before the first, second, and third course of treatment, and a clinical neurological assessment before the first, second, and third course of treatment. Pharmacological studies will include hematologic, liver, and renal function tests as well as cisplatin and doxorubicin plasma levels with blood samples drawn before, during, and up to 12 h after the start of each PIPAC course.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Single-arm, Open-label, Three Step Dose Escalation Study With Intraperitoneal Pressurized Cisplatin and Doxorubicin in Recurrent Ovarian Cancer and Peritoneal Carcinomatosis
Actual Study Start Date : November 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018


Arm Intervention/treatment
Experimental: Cisplatin and doxorubicin
Cisplatin and doxorubicin will be applied under pressure into the abdomen via laparoscopic trocars. The first 5 patients will receive doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 2.25 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 11.25 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 3 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 15 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. This schedule represents a three-step, 50% dose-escalation. Dose density will not be changed.
Drug: Cisplatin and doxorubicin
The first 5 patients will receive doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 2.25 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 11.25 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 3 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 15 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. This schedule represents a three-step, 50% dose-escalation. Dose density will not be changed.
Other Name: Cisplatin TEVA, Doxorubicin 50 HEXAL®

Procedure: Cisplatin and doxorubicin
intraperitoneal chemotherapy with cisplatin and doxorubicin in a dose-escalation scheme
Other Name: Intraperitoneal chemotherapy




Primary Outcome Measures :
  1. Adverse events according to CTCAE criteria [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Clinical benefit according to RECIST criteria [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. Plasma concentrations of cisplatin and doxorubicin [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. clinical and/or radiological evidence of PC,
  2. age between 18 and 85 years with a diagnosis of recurrent ovarian cancer with disease progression after at least one line of previous intravenous chemotherapy with a platinum compound,
  3. blood and electrolyte counts, liver, and renal function parameters within 10% of the normal range established in the respective laboratory of the study institution,
  4. provision of written informed consent, and
  5. postmenopausal status.

Exclusion Criteria:

  1. extraabdominal metastatic disease, with the exception of isolated pleural carcinomatosis/effusion,
  2. chemotherapy or surgery within the last four weeks prior to the first PIPAC application,
  3. previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones,
  4. a history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin,
  5. severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction or severe cardiac arrhythmia,
  6. immunocompromised status such as immunosuppressive therapy or a known disease of the immune system,
  7. previous enrolment in the present study, and
  8. previous intraabdominal chemotherapy or intraabdominal antibody therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475772


Locations
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Germany
Ruhr University Bochum, Germany, Marienhospital Herne
Herne, North-Rhine Westphalia, Germany, 44625
Sponsors and Collaborators
Clemens Tempfer
Investigators
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Principal Investigator: Clemen^s B Tempfer, MD Ruhr University Bochum

Publications:
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Responsible Party: Clemens Tempfer, Chairman, Clinic Director, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT02475772     History of Changes
Other Study ID Numbers: PIPAC-OV2
2014-001034-28 ( EudraCT Number )
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Keywords provided by Clemens Tempfer, Ruhr University of Bochum:
ovarian cancer
recurrent
chemotherapy
intraperitoneal
cisplatin
doxorubicin
Additional relevant MeSH terms:
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Doxorubicin
Liposomal doxorubicin
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Carcinoma
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Cisplatin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action